SCO2T (Servo vs. Servo)

Summary

Most premature babies require oxygen therapy. There is uncertainty about what oxygen levels are the best. The oxygen levels in the blood are measured using a monitor called a saturation monitor and the oxygen the baby breathes is adjusted to keep the level in a target range. Although there is evidence that lower oxygen levels maybe harmful, it is not known how high they need to be for maximum benefit. Very high levels are also harmful. Saturation monitors are not very good for checking for high oxygen levels. For this a different kind of monitor, called a transcutaneous monitor, is better.

Keeping oxygen levels stable is usually done by nurses adjusting the oxygen levels by hand (manual control). There is also equipment available that can do this automatically (servo control). It is not known which is best.

Studies of automated control have shown that infants spend more time within their intended target oxygen saturation range. These have not included measurements of transcutaneous oxygen. There are no previous studies directly comparing automated respiratory devices.

The investigators aim to show the transcutaneous oxygen levels as well as the oxygen saturation levels when babies have their oxygen adjusted using two automated (servo) control devices delivering nasal high flow.

For a period of 12 hours each baby will have their oxygen adjusted automatically using each devices for 6 hours respectively. The investigators will compare the range of oxygen levels that are seen between the two respiratory devices.

Conditions

• Premature Infant
• Oxygen Therapy
• Hypoxia
• Hyperoxia
• Obstetric Labor, Premature

Interventions

DEVICE

Servo control (closed-loop automatic control of the inspiratory fraction of oxygen (FiO2)) - Leoni plus CLAC

FiO2 adjustments will be made by the Leoni plus CLAC (Closed-Loop Automated oxygen Control) ventilator (Leoni plus, Löwenstein Medical, Germany). Manual adjustments of the inspired oxygen fraction can additionally be made as per standard care.

DEVICE

Servo control (closed-loop automatic control of the inspiratory fraction of oxygen (FiO2)) - IntellO2 OAM

FiO2 adjustments will be made by the IntellO2 Oxygen Assist Module (OAM) for Precision Flow (IntellO2, Vapotherm, USA). Manual adjustments of the inspired oxygen fraction can additionally be made as per standard care.

Sponsors & Collaborators

• NHS Lothian

  collaborator OTHER_GOV

• University of Edinburgh

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

2 Days

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-08-10

Primary Completion

2023-05-03

Completion

2023-05-03

Countries

• United Kingdom

Study Locations